Site Start-up Specialist

CDD is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in. It is an exciting time for CDD as we're expanding our teams to move forward with an ambitious new strategy to maximise the impact of our research to benefit patients. As a site start up specialist you will work within a multidisciplinary team on a selection of early phase clinical trials. Your focus will be to expedite site/investigator selection and to open sites to recruitment in the most efficient and expedited way possible, fully understanding the sponsor's requirements and timeline. You'll be a confident communicator and have the ability to develop good relationships with Investigators, project teams and site personnel to ensure that Cancer Research UK clinical trials are set-up efficiently, to budget and to time. You'll also work closely with our Clinical Research Associate (CRA) team on monitoring phase 1 and 11 clinical trials, supporting them with monitoring dependent on business need. What will I be doing?

• Research potential sites and provide a list of sites to be taken forward for full feasibility
• Discuss the requirements of the trial with the Clinical Study Manager (CSM) and Senior Site Start-up Specialist (SSSS).
• Identify challenges that may need to be overcome by a site in order to take part in the clinical trial;
• Draft, finalise and distribute feasibility questionnaires as deemed necessary by the CSM and SSSS and collate the responses. If required, they will ensure confidentiality agreements (CDAs) are in place before sending out confidential information;
• Perform pre-study visits either in person or virtually in order to determine the responses to any feasibility questions or to address any concerns, including those raised from previous collaborations with the site;
• Present all findings and recommendations to the CSM and SSSS so a joint decision can be taken on suitable sites for the trial, as well as being able to work across the project team;
• Work with the CRA assigned to the trial/site to ensure that the sites are successfully handed over which includes, but is not limited to, arranging/delivering the SIV, organising the document pack for sites and collating/approving all required documents. This will be agreed on a site by site basis.
  
  Experience of site selection, site set-up and monitoring (if possible) of a clinical trial (oncology desirable but not essential);
• Experience of working with clinical trials of investigational medicinal products (CTIMPs)
• Working knowledge of oncology; the National Health Service; UK regulations; and the clinical trial application process (different requirements of the Devolved Nations is desirable but not essential as training will be provided)
• An understanding of the relevant protocol investigations e.g. Response Evaluation Criteria for Solid Tumours (RECIST), Ionising Radiation (Medical Exposure) Regulations (IRMER); Advanced Therapy Medicinal Product (ATMP) Regulations (as needed), etc., this will vary from trial to trial;
• They must be a clear communicator; confident in to speaking knowledgably with site staff; represent the Sponsor in a professional manner;
• They must have good negotiation skills to be able to support with the negotiation of costs and contracts.
Our organisation values are designed to guide all that we do. Bold: Act with ambition, courage and determination Credible: Act with rigour and professionalism

We're looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer. If you're interested in applying and excited about working with us but are unsure if you have the right skills and experience we'd still love to hear from you. Join us and help shape the future of how we support people affected by cancer. Together, we'll go further - faster. Our organisation values are designed to guide all that we do. Bold: Act with ambition, courage and determination Credible: Act with rigour and professionalism Human: Act to have a positive impact on people Together: Act inclusively and collaboratively We're looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer. What will I gain? We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high-quality tools. Our policies and processes enable you to improve your work-life balance, take positive steps in your career and achieve your personal wellbeing goals.